Disposable Nasopharyngeal Airway Market Trends and Compliance Requirements 2025

As global demand for airway management solutions continues to rise in emergency, trauma, and tactical medical environments, disposable nasopharyngeal airway kits have become essential medical tools. Known for their ease of use, reduced infection risk, and rapid deployment, these devices are increasingly favored by healthcare providers, military medics, and OEM suppliers alike.

Bever Medical shares the nasopharyngeal airway kit market's growth trends and regulations in this article. We aim to help distributors, medical device companies, and OEM customers navigate this expanding industry segment. Take a quick look now.

Market and Industry Overview

The disposable nasopharyngeal airway market shows strong growth potential. Market research indicates the market was valued at USD 1.5 billion in 2024 and is projected to reach USD 2.5 billion by 2033, with a compound annual growth rate (CAGR) of 6.5%. Meanwhile, the broader nasopharyngeal airway market (including reusable variants) is expected to grow from USD 250 million to USD 450 million in the same period, at a CAGR of 7.5%.

Key Drivers of Market Growth

• Rising prevalence of respiratory emergencies and trauma cases
• Increased adoption of minimally invasive airway management techniques
• The growing elderly population requires pre-hospital care
• Expanding use in tactical and military rescue operations

Applications in Emergency and Military Medicine

Nasopharyngeal airway kits play a vital role in pre-hospital, battlefield, and disaster medicine. In tactical combat casualty care (TCCC), compromised airways are the second leading cause of potentially survivable battlefield deaths, after hemorrhage. Combat medics depend on these kits for rapid, safe airway access in high-stress scenarios. There are some advantages in field use:

• Suitable for unconscious or semi-conscious patients with intact gag reflexes
• Preferred over oropharyngeal airways in field conditions
• Helps facilitate bag-valve-mask ventilation
• Lightweight and compact for outdoor emergency kits

Regulatory Compliance Requirements

FDA Regulations (United States)

In the U.S., the FDA classifies nasopharyngeal airways under product code BTQ, Class I medical devices (21 CFR 868.5100). These devices are 510(k) exempt, meaning no premarket notification is required. However, manufacturers must:

• Register their establishment
• Comply with Quality System Regulations (QSR)
• Prepare for the QMSR Final Rule (effective Feb 2, 2026), which harmonizes U.S. regulations with ISO 13485:2016

CE Marking (European Union)

Under the EU MDR, nasopharyngeal airways must:

• Comply with ISO 13485 quality systems
• Meet safety and performance criteria
• Provide labeling per EN 1041

Ensure sterile packaging in line with EN 556-1, with a sterility assurance level (SAL) of 10⁻⁶ or lower, meaning ≤1 viable microorganism per 1,000,000 devices

ISO Standards and Sterilization Requirements

ISO 13485 Quality Management Systems

This global standard outlines specific requirements for medical device QMS, covering:

• Risk management and regulatory controls
• Production and post-market surveillance
• Continuous improvement and traceability

Implementing ISO 13485 signals that the manufacturer produces safe, effective devices that meet global compliance standards.

Sterilization Validation

For disposable nasopharyngeal airways, sterilization must be validated under:

• ISO 11135 (ethylene oxide)
• ISO 11137 (radiation sterilization)

The sterilization process must ensure:

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

All documented to confirm consistent SAL 10⁻⁶ sterility while preserving product functionality.

OEM Manufacturing Considerations

OEM Service Advantages

OEMs offer end-to-end solutions for nasopharyngeal airway kits, including:

• Product design and engineering
• Regulatory support (FDA, CE, ISO)
• Scalable manufacturing and technical documentation

By outsourcing to OEMs, medical brands reduce cost, shorten time to market, and shift compliance risks to trusted experts.

Contract Manufacturing Benefits

Contract manufacturers offer flexibility and customization, such as:

• Material selection and lubricant packaging
• Pediatric and adult size ranges
• Prototyping, sample validation, and batch production

These services allow companies to deliver tailored products without building in-house production lines.

Product Features and Selection Criteria

Key Design Features

• Made from medical-grade PVC, soft yet structurally sound
• Rounded, lubricated tips for smooth insertion
• Flared ends prevent migration
• Available in multiple sizes: pediatric to adult
• Individually packaged and sterile 

Selection Guidelines

Healthcare professionals should assess:

• Proper sizing: smaller than the patient’s nostril diameter
• Biocompatibility: latex-free and non-allergenic materials
• Flexibility: to prevent kinking during use
• Sterility: ensure clear labeling and expiration dates

Contact Bever Medical Today

Bever Medical specializes in FDA- and CE-certified disposable nasopharyngeal airway kits that meet global quality standards. Our OEM and contract manufacturing services are trusted by leading emergency medical and military organizations worldwide.

Any interests, please feel free to contact us to request a quote for bulk orders or explore custom solutions for your airway management needs.